Assess the Efficacy and Safety of Multi-target Therapy in Lupus Nephritis

Completed 362 enrolled Zhi-Hong Liu, M.D. Beijing Friendship Hospital · collab China Medical University, China · collab Huashan Hospital · collab RenJi Hospital · collab Ruijin Hospital · collab Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · collab The First Affiliated Hospital with Nanjing Medical University · collab West China Hospital · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the efficacy and safety of multi-target therapy in the treatment of class Ⅲ,Ⅳ,Ⅴ,Ⅲ+Ⅴand Ⅳ+Ⅴ lupus nephritis.

Timeline

Start: 2009-04
Primary completion: 2011-05
Completion: 2012-02

Outcome

Met primary endpoint

paper After 24 weeks of therapy, more patients in the multitarget group (45.9%) than in the intravenous cyclophosphamide group (25.6%) showed complete remission PMID 25383558 ↗

paper complete remission (difference, 20.3 percentage points [95% CI, 10.0 to 30.6 percentage points]; P < 0.001). PMID 25383558 ↗

Publications

Liu Z, Zhang H, Liu Z, Xing C, Fu P, Ni Z, Chen J, Lin H, Liu F, He Y, He Y, Miao L, Chen N, Li Y, Gu Y, Shi W, Hu W, Liu Z, Bao H, Zeng C, Zhou M. Multitarget therapy for induction treatment of lupus nephritis: a randomized trial. Ann Intern Med. 2015 Jan 6;162(1):18-26. doi: 10.7326/M14-1030.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Cyclophosphamide	Other / unclassified	0.75 g	Intravenous
Subject	Mycophenolate Mofetil	Small molecule	1 g	—
Subject	Tacrolimus	Small molecule	4 mg	—